Physical Activity Immediately After Acute Cerebral Ischemia 3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01712282
Recruitment Status : Unknown
Verified March 2013 by Anna Maria Strømmen, Hillerod Hospital, Denmark.
Recruitment status was:  Recruiting
First Posted : October 23, 2012
Last Update Posted : March 14, 2013
Information provided by (Responsible Party):
Anna Maria Strømmen, Hillerod Hospital, Denmark

Brief Summary:

Stroke is the leading cause of adult disability in Europe and United States and the second leading cause of death worldwide and affects more than 10,000 Danes each year.

Studies in a late and stationary phase after stroke have shown that physical rehabilitation is of great importance for survival and physical ability of these patients, however many studies show that patients lie or sit next to their bed under hospitalization for more than 88.5 % of the daily hours. Physical activity in stroke patients has never previously been measured immediately after debut of symptoms; furthermore there is no knowledge about the optimal dose of physical rehabilitation for these patients.

Accelerometers, small measuring devices, are a relatively new way to measure physical activity precisely, and hence it is possible to obtain an objective measure of how active stroke patients are in the first week after admission. The accelerometers measure a variable voltage, depending on the range and intensity of movement. They can measure movement dependent of the placement of the accelerometer, for instance over the hip, arm or leg. Studies confirm their reliability, even in patients with abnormal gait, such as stroke patients.

Another approach of studying the effects of physical activity and rehabilitation is through the examination of biomarkers. Studies have shown that biomarkers released during physical activity can inhibit biomarkers released after tissue injury in the brain, as seen after stroke. These brain biomarkers cause further damage and studies show that the higher the levels, the higher the damage. It is therefore obvious to examine whether physical activity rehabilitation can down regulate this destructive process in patients with stroke.

Clarification of the optimal dose of physical activity in stroke patients immediately after debut of symptoms and examination of both the biochemical aspects of physical rehabilitation as well as the optimal dose of physical rehabilitation is of great importance for many patients, their relatives as well as of a great socioeconomic importance.

The purpose of the project is to investigate feasibility of treadmill training on a weight-bearing treadmill in the acute phase after admission after an ischemic stroke. Furthermore we wish to investigate the acute inflammatory response after ischemic stroke and whether it changes with treadmill training.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Behavioral: physical activity, 2 x 30 minutes/day Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much
Study Start Date : December 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: High dose training
2 x 30 minutes/day on a weight-bearing treadmill
Behavioral: physical activity, 2 x 30 minutes/day
weight-bearing treadmill, pulse reserve increase of 50%

Primary Outcome Measures :
  1. Level of inflammation, under, during and after treadmill training [ Time Frame: up to 5 days ]
    Biomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Necrosis Factor(TNF)-alpha, C-Reactive Protein (CRP), IL-1ra, IL-10, fasting-insulin, fasting-glucose

Secondary Outcome Measures :
  1. Correlation of biomarker level [ Time Frame: up to 5 days ]
    Correlation with time, activity counts on an accelerometer, Scandinavian Stroke Scale Score (SSS), National Institutes of Health Stroke Scale score (NIHSS), Glasgow Coma Scale (GCS), Barthels Index-100 (BI), 10 Meters Walking Test (10MWT), modified Rankin Scale (mRS), Assessment of Motor and Process Skills (AMPS), Bergs Balance test, age, Body Mass Index and sex

  2. Feasibility [ Time Frame: up to 5 days ]
    Whether it is feasible/possible to train patients on a treadmill in the acute phase after ischemic stroke; eg. whether patients are too exhausted to train twice daily, experience complications during training such as nausea or dizziness and therefore can't complete the training programme.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients admitted with acute ischemic stroke
  • age > 18 years
  • first stroke or only minor invalidity from previous strokes (mRS 0-2)
  • truncal stability
  • SSS score for arm and leg: 10 out of 12 points

Exclusion Criteria:

  • symptoms attributable to other diseases than ischemic stroke
  • debut of symptoms > 48 h prior to admission
  • consent not given < 24 h of admission
  • pregnancy or lactation
  • isolation
  • blood sampling generally not possible
  • allergy due to accelerometer wear
  • ulcers or other skin diseases in the area of accelerometer placement
  • unstable cardiologic condition (AMI etc.)
  • acute high and sustained resting systolic blood pressure where treatment is necessary
  • acute heart rhythm disorder where treatment is necessary
  • unable to cooperate
  • significant orthopedic conditions (fractures etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01712282

Contact: Anna M Strømmen, MD +4548297353

Hillerød Hospital Recruiting
Hillerød, Denmark, 3400
Contact: Anna Maria Strømmen, MD    +4548297353   
Principal Investigator: Anna Maria Strømmen, MD         
Sponsors and Collaborators
Hillerod Hospital, Denmark

Responsible Party: Anna Maria Strømmen, clinical assistant, Hillerod Hospital, Denmark Identifier: NCT01712282     History of Changes
Other Study ID Numbers: 30704 part 3
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013

Keywords provided by Anna Maria Strømmen, Hillerod Hospital, Denmark:
Physical Activity

Additional relevant MeSH terms:
Brain Ischemia
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction